[Technical Field]
[0001] The present invention relates to: an oral tablet composition comprising dexlansoprazole;
an oral tablet comprising the same; and a method for manufacturing the same, and more
particularly, to an oral tablet composition, which may be used to manufacture a tablet
having improved hardness, disintegration time, and friability by comprising mannitol
having a specific size, a disintegrating agent, and a lubricant together with amorphous
dexlansoprazole; an oral tablet comprising the same; and a method for manufacturing
the same.
[Background Art]
[0002] Dexlansoprazole acts as a proton pump inhibitor (PPI) having actions such as a gastric
acid secretion suppressive action or a gastric mucosal protective action, and has
been widely used as a therapeutic agent for peptic ulcers, and the like.
[0003] However, the dexlansoprazole is poorly soluble in water and very unstable in acids,
and thus is easily decomposed in gastric juice, which is an acidic solution. Further,
pH affects the stability of dexlansoprazole in an aqueous solution state. Accordingly,
for effective in vivo delivery of dexlansoprazole through oral administration, there
is a need for a dosage form in which dissolution characteristics in the upper small
intestine portion are improved while the loss of activity caused by gastric juice
is minimized by enteric coating.
[0004] Thus, in the related art, a method for manufacturing a pharmaceutical formulation
by coating a pharmaceutical formulation in a dosage form of a granule, pellet, tablet,
or capsule with an enteric material or using a capsule comprising an enteric material
has been used.
[0005] For example, Patent Document 1 (
US 2011/0189271 A1) discloses a pharmaceutical formulation comprising: (a) a pharmacologically inert
core; (b) a drug layer surrounding the core and comprising dexlansoprazole, or a salt
thereof, and one or more pharmaceutically acceptable excipients; (c) an intermediate
layer surrounding the drug layer; and (d) an enteric layer surrounding the intermediate
layer. In this case, Patent Document 1 discloses that the dexlansoprazole or the salt
thereof is amorphous, and the pharmaceutical formation may be formulated in a dosage
form of a tablet or capsule.
[0006] In addition, Patent Document 1 describes a method for preparing the pharmaceutical
formulation, comprising: (a) combining dexlansoprazole, a metal compound, and one
or more pharmaceutically acceptable excipients with a solvent, to prepare a dexlansoprazole
solution; (b) spraying the dexlansoprazole solution obtained in (a) onto a pharmacologically
inert core; (c) spraying an intermediate layer onto the drug-coated core obtained
in (b); and (d) spraying an enteric coating layer onto the intermediate layer-coated
core obtained in (c).
[0007] Referring to the examples described in the above document, methods of processing
a pharmaceutical formulation comprising dexlansoprazole into a pellet form through
various steps and formulating the pharmaceutical formulation in the pellet form into
a dosage form of a tablet or capsule are disclosed. However, according to the method,
the amorphous raw material is recrystallized, so that the drug cannot be released
as pure amorphous dexlansoprazole. In addition, when a tablet is prepared by using
dexlansoprazole processed into the pellet form as in Patent Document 1, hardness may
deteriorate or the disintegration time may be delayed, and friability is high, so
that a problem in that the stability of the tablet deteriorates may also occur, and
as the production process becomes complicated, there is a disadvantage in that the
production efficiency deteriorates.
[Prior Art Document]
[Patent Document]
[Disclosure]
[Technical Problem]
[0009] The present invention intends to provide an oral tablet composition, which may be
used to manufacture a tablet having improved hardness, disintegration time, and friability
by comprising mannitol having a specific size, a disintegrating agent, and a lubricant
together with amorphous dexlansoprazole; and an oral tablet comprising the same.
[0010] Further, the present invention intends to provide a method for manufacturing an oral
tablet, in which the production process is simplified using a dry direct compression
method.
[Technical Solution]
[0011] To address the aforementioned problems, the present invention provides an oral tablet
composition comprising amorphous dexlansoprazole, mannitol having an average particle
size of 100 to 400 µm, a disintegrating agent and a lubricant.
[0012] The composition may comprise 0.1 to 20 wt% of the amorphous dexlansoprazole, 20 to
50 wt% of the mannitol, 25 to 55 wt% of the disintegrating agent, and 0.5 to 5 wt%
of the lubricant.
[0013] The amorphous dexlansoprazole may have an average particle size of 0.1 to 15 µm.
[0014] The disintegrating agent may comprise one or more selected from the group consisting
of microcrystalline cellulose, low-substituted hydroxypropyl cellulose, croscarmellose
sodium, sodium starch glycolate, carboxymethyl cellulose sodium, carboxymethyl cellulose
calcium, and crospovidone.
[0015] The lubricant may comprise one or more selected from the group consisting of magnesium
stearate, stearic acid, zinc stearate, calcium stearate, sodium stearyl fumarate,
talc, silicon dioxide, and colloidal silicon dioxide.
[0016] Meanwhile, the present invention provides an oral tablet comprising the oral tablet
composition.
[0017] The friability of the oral tablet may be 0.01 to 0.5%.
[0018] In this case, the oral tablet may further comprise a core comprising the oral composition,
an aqueous coating layer covering a surface of the core, and an enteric coating layer
covering a surface of the aqueous coating layer.
[0019] The aqueous coating layer may comprise one or more selected from the group consisting
of cellulose ether, polyvinylpyrrolidone, and polyvinyl alcohol, and the cellulose
ether may comprise one or more selected from the group consisting of hydroxypropyl
cellulose, hydroxypropyl methyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose,
hydroxybutyl cellulose, hydroxypentyl cellulose, and hydroxypropyl butyl cellulose.
[0020] The enteric coating layer may comprise one or more selected from the group consisting
of hydroxypropyl methyl cellulose phthalate (HPMCP), hydroxypropyl methyl cellulose
acetate succinate (HPMCAS), cellulose acetate phthalate, and derivatives thereof.
[0021] Further, the present invention provides a method for manufacturing the oral tablet,
the method comprising: steps of (1) mixing amorphous dexlansoprazole, mannitol having
an average particle size of 100 to 400 µm, and a disintegrating agent; (2) inputting
and mixing a lubricant into the mixture obtained according to Step (1); and (3) compressing
the mixture obtained according to Step (2).
[0022] The compression in Step (3) may be a dry direct compression method.
[0023] Moreover, the manufacturing method may further comprise: steps of coating the mixture
compressed according to Step (3) with an aqueous coating layer; and coating a surface
of the aqueous coating layer with an enteric coating layer.
[Advantageous Effects]
[0024] According to the present invention, it is possible to provide an oral tablet having
excellent hardness, a shortened disintegration time, and at the same time improved
friability by providing an oral tablet composition comprising mannitol having a specific
size, a disintegrating agent, and a lubricant together with amorphous dexlansoprazole.
[0025] In addition, in the method for manufacturing an oral tablet according to the present
invention, a dry direct compression method is used as the method for manufacturing
the oral tablet, and thus an increase in production efficiency by simplifying the
production process can be achieved.
[0026] Moreover, according to the present invention, the oral tablet was designed as a double-coated
tablet to effectively suppress the drug from being released in the stomach and to
release the drug in the intestines (pH 5.5 or more).
[Description of Drawings]
[0027] FIG. 1 is a graph illustrating the dissolution test results of the oral tablet manufactured
according to Example 1.
[Modes of the Invention]
[0028] The present invention relates to an oral tablet composition comprising dexlansoprazole,
an oral tablet comprising the same, and a manufacturing method thereof.
[0029] First, referring to an oral tablet composition, the composition includes amorphous
dexlansoprazole, mannitol having an average particle size of 100 to 400 µm, a disintegrating
agent, and a lubricant.
[0030] The amorphous dexlansoprazole is the main ingredient of the oral tablet according
to the present invention, one of the proton pump inhibitors (PPIs) as described above,
and has been widely used as a therapeutic agent for peptic ulcers. The dexlansoprazole
is an optical isomer of lansoprazole, and is a compound represented by the following
Chemical Formula 1.
[0031] A content of the amorphous dexlansoprazole may be 0.1 to 20 wt% based on 100 wt%
of the oral tablet composition, and when the content is less than 0.1 wt%, there is
a risk that the efficacy is insignificant, whereas when the content is more than 20
wt%, the content exceeds a daily intake, so that there is a risk that a side effect
due to the overdose occurs.
[0032] The amorphous dexlansoprazole may have an average particle size of 0.1 to 15 µm,
and when the average particle size is less than 0.1 µm, there is a risk that the productivity
deteriorates, whereas when the average particle size is more than 15 µm, there is
a risk that the absorption rate in the body deteriorates.
[0033] As described above, it is possible to manufacture an oral tablet which is excellent
in solubility and dissolution characteristics of the drug by using amorphous dexlansoprazole.
However, the dexlansoprazole having such an amorphous form has poor flowability of
the powder, so that a problem may occur during the compression into tablets, and the
dexlansoprazole exhibits thermodynamically unstable characteristics under high temperature
and humidity conditions, so that there is a disadvantage that it is difficult to mold
the dexlansoprazole into wet granules. Thus, as a result of intensive studies to solve
these problems, the present inventors confirmed that when mannitol having an average
particle size of 100 to 400 µm is included together with amorphous dexlansoprazole,
the flowability of an oral tablet composition including amorphous dexlansoprazole
could be enhanced, and as a result, an oral tablet composition which is excellent
in fluidity may be provided, thereby completing the present invention.
[0034] When the average particle size of the mannitol is out of a range of 100 to 400 µm,
the flowability of the oral tablet composition comprising dexlansoprazole deteriorates
and mixing uniformity deteriorates, so that filling properties are adversely affected,
thereby adversely affecting content uniformity and tablet compression pressure.
[0035] A content of the mannitol may be 20 to 50 wt% based on 100 wt% of the oral tablet
composition, and when the content is less than 20 wt%, there is a risk that an effect
of contributing to improvement in flowability of the oral tablet composition including
amorphous dexlansoprazole is insignificant, whereas when the content is more than
50 wt%, there is a risk that the disintegration time of the tablet is delayed or the
dissolution rate thereof deteriorates.
[0036] The disintegrating agent (disintegrant) serves to facilitate breakup or disintegration
of the solid dosage form after oral administration. The disintegrating agent may comprise
one or more selected from the group consisting of microcrystalline cellulose, low-substituted
hydroxypropyl cellulose, croscarmellose sodium, sodium starch glycolate, carboxymethyl
cellulose sodium, carboxymethyl cellulose calcium, and crospovidone.
[0037] A content of the disintegrating agent may be 25 to 55 wt% based on 100 wt% of the
oral tablet composition, and when the content is less than 25 wt%, there is a risk
that the drug is poorly released in the body, whereas when the content is more than
55 wt%, there is a risk that it is difficult to maintain an appropriate hardness.
[0038] The lubricant serves to improve the fluidity of amorphous dexlansoprazole particles,
prevent friction between the particles, and prevent amorphous dexlansoprazole particles
from attaching to a tableting machine. The lubricant may comprise one or more selected
from the group consisting of magnesium stearate, stearic acid, zinc stearate, calcium
stearate, sodium stearyl fumarate, talc, silicon dioxide, and colloidal silicon dioxide.
[0039] A content of the lubricant may be 0.5 to 5.0 wt% based on 100 wt% of the oral tablet
composition, and when the content is less than 0.5 wt%, the fluidity of amorphous
dexlansoprazole particles is reduced and the particles may be attached to a tableting
machine, so that compression may not be easily conducted. On the contrary, when the
content of the lubricant is more than 5.0 wt%, the cohesive force of amorphous dexlansoprazole
particles becomes weak, so that it is difficult to maintain an appropriate hardness,
and a problem in that the disintegration time of the tablet is delayed and the dissolution
rate deteriorates may be caused.
[0040] Meanwhile, the present invention provides an oral tablet comprising the oral tablet
composition. The friability of the oral tablet may be 0.01 to 0.5%, and an oral tablet
which is excellent in physical stability may be provided by having a friability within
the range.
[0041] The oral tablet provided according to the present invention may further comprise
a core comprising the oral composition, an aqueous coating layer covering a surface
of the core, and an enteric coating layer covering a surface of the aqueous coating
layer. By designing the oral tablet as a double-coated tablet as described above,
since acid resistance is secured, the release of the drug in the stomach may be suppressed
and the release of the drug in the intestines may be promoted, and accordingly, the
drug-taking compliance of a patient may be improved.
[0042] The enteric coating layer is a coating layer disposed at the outermost portion of
the oral tablet according to the present invention, and serves to suppress the drug
from being released in the stomach. As used herein, "enteric" refers to a property
in which disintegration and dissolution are not achieved under a gastric juice condition
(around pH 1.2) for 2 hours and disintegration and dissolution are achieved under
a small intestine condition (around pH 7.2) in a short period of time within 1 hour,
and the enteric coating layer refers to a coating layer including a material having
enteric properties.
[0043] The enteric coating layer may comprise one or more selected from the group consisting
of hydroxypropyl methyl cellulose phthalate (HPMCP), hydroxypropyl methyl cellulose
acetate succinate (HPMCAS), cellulose acetate phthalate, and derivatives thereof.
[0044] The aqueous coating layer is a coating layer present between a core comprising the
oral tablet composition and the enteric coating layer, and serves to allow the enteric
coating layer to be effectively and stably applied and minimize effects of dexlansoprazole
on pH during the coating of the enteric coating layer.
[0045] The aqueous coating layer may comprise one or more selected from the group consisting
of cellulose ether, polyvinylpyrrolidone, and polyvinyl alcohol. In this case, the
cellulose ether may comprise one or more selected from the group consisting of hydroxyalkyl
cellulose and hydroxyalkyl alkyl cellulose, and may preferably comprise one or more
selected from the group consisting of hydroxypropyl cellulose, hydroxypropyl methyl
cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxybutyl cellulose,
hydroxypentyl cellulose, and hydroxypropyl butyl cellulose.
[0046] Further, the present invention provides a method for manufacturing the oral tablet,
the method comprising: steps of (1) mixing amorphous dexlansoprazole, mannitol having
an average particle size of 100 to 400 µm, and a disintegrating agent; (2) inputting
and mixing a lubricant into the mixture obtained according to Step (1); and (3) compressing
the mixture obtained according to Step (2).
[0047] The amorphous dexlansoprazole, the mannitol, the disintegrating agent, and the lubricant
may be subjected to a sieving process in order to have a desired particle size.
[0048] The compression in Step (3) may be a dry direct compression method, and the production
process may be simplified by using a dry direct compression method of directly compressing
the mixture obtained according to Step (2), thereby enhancing the production efficiency.
In addition, since the dry direct compression method is not used in the present invention,
the crystal form of amorphous dexlansoprazole is not deformed during the process of
manufacturing the oral tablet. Therefore, when amorphous dexlansoprazole is used as
a raw material, the amorphous dexlansoprazole may be comprised as it is in an oral
tablet to be finally obtained, and consequently, pure amorphous dexlansoprazole may
be released in vivo. Accordingly, an oral tablet which is excellent in solubility
and dissolution characteristics may be provided according to the present invention.
[0049] The method for manufacturing an oral tablet according to the present invention may
further comprise: steps of coating the mixture compressed according to Step (3) with
an aqueous coating layer; and coating a surface of the aqueous coating layer with
an enteric coating layer. Accordingly, since a double-coated oral tablet is manufactured,
acid resistance of the tablet may be secured and the drug-taking compliance of a patient
may be enhanced.
[0050] Hereinafter, the present invention will be described in more detail with reference
to examples, but the present invention is not limited to these examples.
Example 1
[0051] As described in Table 1, a first mixture was prepared by mixing 15.3 wt% of amorphous
dexlansoprazole, 28.0 wt% of mannitol in the form of a granule, and 53.4 wt% of a
disintegrating agent. In this case, the amorphous dexlansoprazole had an average particle
size of 15 µm, and the mannitol in the form of a granule had an average particle size
of 320 µm. Moreover, the disintegrating agent consists of 12.7 wt% of crospovidone,
25.4 wt% of sodium starch glycolate, and 15.3% of low-substituted hydroxypropyl cellulose.
[0052] Subsequently, a second mixture was prepared by inputting 3.3 wt% of a lubricant to
the first mixture and mixing. In this case, the lubricant consists of 2.3 wt% of light
anhydrous silicic acid and 1.0 wt% of magnesium stearate.
[0053] Subsequently, an oral tablet in the form of a tablet having a diameter of 1 cm was
manufactured by compressing and tableting the second mixture with a tableting device
(KeumSung Machinery Co., Ltd., KTSS).
[0054] Subsequently, the surface of the oral tablet was coated by spraying an aqueous coating
layer onto the surface of the oral tablet. In this case, a coating composition used
in the formation of an aqueous coating layer was prepared by inputting 6.7 wt% of
hydroxypropyl methyl cellulose (HPMC) (Lotte Fine Chemical Co., Ltd., AN6) to 89.6
wt% of an aqueous ethanol solution (concentration of 10%) and dissolving, and then
adding 0.7 wt% of a coating agent polyethylene glycol 6000 (Merck Millipore, PEG 6000)
and 3.0 wt% of titanium dioxide (Sigma Aldrich, titanium (IV) oxide) thereto.
[0055] Subsequently, a tablet coated for oral use was manufactured by spray-coating the
surface of the tablet coated with the aqueous coating layer with an enteric coating
layer. In this case, a coating composition used in the formation of the enteric coating
layer was prepared by inputting 7.8 wt% of hydroxypropyl methyl phthalate (Lotte Fine
Chemical Co., Ltd., HPMCP HP-55) to 90.6 wt% of an aqueous ethanol solution (concentration
of 10%) and dissolving, and then adding 0.8 wt% of a coating agent glycerin fatty
acid ester (Mitsubishi, Polyglycerin esters) and 0.8 wt% of titanium dioxide (Sigma
Aldrich, titanium (IV) oxide) thereto.
Examples 2 and 3 and Comparative Example 1
[0056] Oral tablets and tablets coated for oral use were manufactured in the same manner
as in Example 1, except that mannitol having particle sizes described in the following
Table 1 was used instead of the mannitol having an average particle size of 320 µm
in the form of a granule.
<Evaluation Method>
1. Hardness (kp)
[0057] The hardness of each of the oral tablets manufactured according to Examples 1 to
3 and Comparative Example 1 was measured using a hardness meter (Pharma Test, PTB-311).
2. Friability (%)
[0058] The friability of each of the oral tablets manufactured according to Examples 1 to
3 and Comparative Example 1 was measured using a friability tester (Pharma Test, PTF-20ER).
3. Disintegration time (sec)
[0059] The disintegration time of each of the oral tablets manufactured according to Examples
1 to 3 and Comparative Example 1 was measured in accordance with the disintegration
test method of the
Korean Pharmacopoeia (11th Edition). Specifically, after the oral tablet was input to a test tube containing 900 ml
of a phosphate buffer with a pH of 6.8, the disintegration time was evaluated as the
time taken for the oral tablet to be completely disintegrated.
4. Dissolution test
[0060] The dissolution rates of the tablets coated for oral use coated with the aqueous
coating layer and the enteric coating layer were evaluated under the following conditions
according to Examples 1 to 3 and Comparative Example 1, and the results thereof are
illustrated in FIG. 1.
- Dissolution method: Dissolution second method (paddle method) of the Korean Pharmacopoeia
- Type of dissolution tester: manufacturer - ERWEKA GmbH, Type - DT 1420
- Type of dissolution solution: pH1.2 (acid stage), pH7.2 (buffer stage)
- Amount of dissolution solution: 900 mL
- Temperature of dissolution solution: 37°C
- Paddle speed: 100 rpm
[0061] In this case, after the dissolution test began in an aqueous solution with a pH of
1.2, 120 minutes later, the test was performed for a total of 210 minutes by changing
the acid solution into a solution with a pH of 7.2, containing 5 mM sodium lauryl
sulfate.
[Table 1]
|
Example 1 |
Example 2 |
Example 3 |
Comparative Example 1 |
Dexlansoprazole (wt%) |
15.3 |
15.3 |
15.3 |
15.3 |
Mannitol (wt%) |
Granule form (320 µm)a |
28.0 |
- |
- |
- |
Powder form (210 µm)b |
- |
28.0 |
- |
- |
Spray-dried form (125 µm)c |
- |
- |
28.0 |
- |
Powder form |
- |
- |
- |
28.0 |
Disintegrating agent |
Crospovidone |
12.7 |
12.7 |
12.7 |
12.7 |
Sodium starch glycolate |
25.4 |
25.4 |
25.4 |
25.4 |
Low-substituted hydroxypropyl cellulose |
15.3 |
15.3 |
15.3 |
15.3 |
Lubricant (wt%) |
Light anhydrous silicic acid |
2.3 |
2.3 |
2.3 |
2.3 |
Magnesium stearate |
1.0 |
1.0 |
1.0 |
1.0 |
Hardness (kp) |
18 |
20 |
14 |
9 |
Friability (%) |
0.12 |
0.14 |
0.25 |
0.48 |
Disintegration time (sec) |
48 |
42 |
60 |
128 |
* Dexlansoprazole: Amino Chemicals/ Dexlansoprazole Amorphous
* Mannitol
- a (mannitol having an average particle size of 320 µm in the form of a granule)
: SPI Pharma / Granulated Mannogem
- b (mannitol having an average particle size of 210 µm in the form of powder)
: SPI Pharma / Pharmasperse® 416
- c (spray-dried mannitol having an average particle size of 125 µm)
: SPI Pharma / Spray-dried Mannogem
- d (mannitol having an average particle size of 75 µm in the form of powder)
: SPI Pharma / Mannogem powder
* Crospovidone: Ashland / Polyplasdone XL
* Sodium starch glycolate: JRS / Sodium starch glycolate
* Low-substituted hydroxypropyl cellulose: ShinEtsu / L-HPC (LH-22)
* Light anhydrous silicic acid: Evonik / Aerosil 200 Pharma
* Magnesium stearate: Nitika / TABLUBE TM |
[0062] Referring to Table 1, it can be confirmed that in the case of the oral tablets comprising
mannitol having an average particle size of 100 to 400 µm manufactured according to
Examples 1 to 3, the hardness is excellent, the friability is low, and the disintegration
time is short as compared to the oral tablet comprising mannitol having an average
particle size of less than 100 µm manufactured according to Comparative Example 1.
[0063] Further, referring to FIG. 1, it can be confirmed that in the case of the tablet
coated for oral use manufactured according to the present invention, the dissolution
is suppressed in an acid state (pH 1.2) and the dissolution rate is rapidly increased
in a buffered state (pH 7.2). From the confirmation, it can be seen that in the case
of the tablet coated for oral use manufactured according to the present invention,
the dissolution of dexlansoprazole is suppressed in the stomach and promoted in the
intestines, and as a result, the tablet coated for oral use may be effectively delivered
in vivo.
[0064] As described above, the examples disclosed in the present invention are provided
not for limiting the technical spirit of the present invention, but for describing
the technical spirit of the present invention, and the scope of the rights of the
present invention should be interpreted by the following claims, and it should be
interpreted in such a way that all the technical spirit within the equivalent scope
of the present invention are included in the scope of the rights of the present invention.
1. An oral tablet composition comprising amorphous dexlansoprazole, mannitol having an
average particle size of 100 to 400 µm, a disintegrating agent, and a lubricant.
2. The oral tablet composition of claim 1, wherein the composition comprises 0.1 to 20
wt% of the amorphous dexlansoprazole, 20 to 50 wt% of the mannitol, 25 to 55 wt% of
the disintegrating agent, and 0.5 to 5 wt% of the lubricant.
3. The oral tablet composition of claim 1, wherein the amorphous dexlansoprazole has
an average particle size of 0.1 to 15 µm.
4. The oral tablet composition of claim 1, wherein the disintegrating agent comprises
one or more selected from the group consisting of microcrystalline cellulose, low-substituted
hydroxypropyl cellulose, croscarmellose sodium, sodium starch glycolate, carboxymethyl
cellulose sodium, carboxymethyl cellulose calcium, and crospovidone.
5. The oral tablet composition of claim 1, wherein the lubricant comprises one or more
selected from the group consisting of magnesium stearate, stearic acid, zinc stearate,
calcium stearate, sodium stearyl fumarate, talc, silicon dioxide, and colloidal silicon
dioxide.
6. An oral tablet comprising the oral tablet composition according to any one of claims
1 to 6.
7. The oral tablet of claim 6, wherein a friability of the oral tablet is 0.01 to 0.5%.
8. The oral tablet of claim 6, further comprising a core comprising the oral composition,
an aqueous coating layer covering a surface of the core, and an enteric coating layer
covering a surface of the aqueous coating layer.
9. The oral tablet of claim 8, wherein the aqueous coating layer comprises one or more
selected from the group consisting of cellulose ether, polyvinylpyrrolidone, and polyvinyl
alcohol.
10. The oral tablet of claim 9, wherein the cellulose ether comprises one or more selected
from the group consisting of hydroxypropyl cellulose, hydroxypropyl methyl cellulose,
hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxybutyl cellulose, hydroxypentyl
cellulose, and hydroxypropyl butyl cellulose.
11. The oral tablet of claim 8, wherein the enteric coating layer comprises one or more
selected from the group consisting of hydroxypropyl methyl cellulose phthalate (HPMCP),
hydroxypropyl methyl cellulose acetate succinate (HPMCAS), cellulose acetate phthalate,
and derivatives thereof.
12. A method for manufacturing the oral tablet according to claim 6, the method comprising:
steps of (1) mixing amorphous dexlansoprazole, mannitol having an average particle
size of 100 to 400 µm, and a disintegrating agent; (2) inputting and mixing a lubricant
into the mixture obtained according to Step (1); and (3) compressing the mixture obtained
according to Step (2).
13. The method of claim 12, wherein the compression in Step (3) is a dry direct compression
method.
14. The method of claim 12, further comprising: steps of coating the mixture compressed
according to Step (3) with an aqueous coating layer; and coating a surface of the
aqueous coating layer with an enteric coating layer.